Understanding Neonatal Jaundice in Rwanda

Understanding Neonatal Jaundice in Rwanda

Sponsors

Lead Sponsor: University of California, Merced

Collaborator: Rwanda Pediatric Association
Ministry of Health, Rwanda
Rwanda Bio-Medical Center
Child Relief International
D-Rev

Source University of California, Merced
Brief Summary

This study exploits the distribution of low-cost high-quality phototherapy devices (Brilliance by D-Rev) to public hospitals in Rwanda to assess whether the provision of improved technology improves health care for infant jaundice. Specifically, the investigators are interested in measuring whether the provision of an additional high-quality phototherapy device, a known effective treatment for jaundice, successfully translates into improved care of neonatal jaundice in Rwanda where the burden of jaundice is particularly high.

Detailed Description

The Ministry of Health (MIH) in Rwanda has planned to provide Brilliance devices (phototherapy) to 46 public hospitals in Rwanda. The investigators have worked with MIH to have the delivery of these machines be staggered over three phases through random selection. The methodology relies on the staggered distribution of Brilliance devices and survey data collected prior and during delivery dates to evaluate the provision of low-cost high quality phototherapy machines, following the basic design of a staggered randomized controlled trial. Specifically, the investigators will survey all hospitals prior to the receipt of any Brilliance devices to provide a baseline description of the care received in these facilities. These surveys will collect information on the facility itself, including average infant jaundice caseloads and descriptions of recent cases. The investigators will then randomly select 15 hospitals to receive the Brilliance units. Three months after installation of Brilliance has occurred at these facilities (Group 1), another randomly selected subset of 16 facilities (Group 2) will receive their Brilliance machines. Three months after these installations have been completed, the remaining facilities (Group 3) will receive their Brilliance machines. During this period, there will be ongoing data collection from the hospitals, creating a panel dataset on the jaundice-related caseloads at these facilities. The data collected will be akin to collecting hospital records of patients diagnosed with jaundice, but no identifiable patient information will be collected.

Overall Status Completed
Start Date May 29, 2017
Completion Date June 1, 2018
Primary Completion Date June 1, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Length of treatment for infant jaundice Through study completion, an average of 9 months
Length of hospital duration for infant jaundice Through study completion, an average of 9 months
Secondary Outcome
Measure Time Frame
Increased rate of reduction in bilirubin Through study completion, an average of 9 months
Improved Treatment of Jaundice Through study completion, an average of 9 months
Improved Treatment of Jaundice By Not Being Referred Elsewhere Through study completion, an average of 9 months
Improved Treatment of Jaundice by Receiving Phototherapy Through study completion, an average of 9 months
Improved Treatment of Jaundice by Not Sharing Phototherapy Through study completion, an average of 9 months
Improved Treatment of Jaundice by Using Single Phototherapy Device Through study completion, an average of 9 months
Improved Treatment of Jaundice by Reducing Exchange Transfusions Through study completion, an average of 9 months
Improved Treatment of Jaundice by Not Meeting Threshold for Exchange Transfusion Through study completion, an average of 9 months
Enrollment 46
Condition
Intervention

Intervention Type: Device

Intervention Name: Brilliance

Description: The intervention is the provision of the Brilliance phototherapy machines to hospitals. This device is to be provided to facilities regardless of the study -- the study's involvement has been to collaborate with the Ministry of Health so that Brilliance is distributed in a randomized staggered method. In that sense, the study may be considered observational, as the study is not driving whether or not a hospital receives Brilliance, only when it receives Brilliance in a short time frame.

Eligibility

Criteria:

Inclusion Criteria:

- For patient level record (de-identified), diagnosed by the facility for having infant jaundice

- The facilities are included based on selection by the Ministry of Health for receiving additional phototherapy machines.

Exclusion Criteria:

-

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Location
Facility: University Central Hospital of Kigali
Location Countries

Rwanda

Verification Date

March 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of California, Merced

Investigator Full Name: Ketki Sheth

Investigator Title: Assistant Professor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Phase 1

Type: Active Comparator

Description: This is the first set of randomly selected hospitals to receive the intervention (Brilliance device). The intervention to be provided is the phototherapy device, Brilliance. *No individual participants are recruited for this study.

Label: Phase 2

Type: Active Comparator

Description: This is the second set of hospitals to receive the device. For the first three months, they receive no intervention, after which they become part of the "active comparator" arm. The intervention to be provided is the phototherapy device, Brilliance. *No individual participants are recruited for this study.

Label: Phase 3

Type: No Intervention

Description: This is the last set of hospitals to receive the device. For the first six months, they receive no intervention, after which the study is completed and they are given the device Brilliance. *No individual participants are recruited for this study.

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Intervention Model Description: Hospitals (i.e., participants) receive the intervention (i.e., Brilliance phototherapy device) at different times in the study. In the first phase, a set of hospital facilities receive the device. After three months of using the device, another set of hospital facilities receive the device. And after an additional three months (approximately 6 months after the first set of hospitals implemented their device), all hospitals will have been provided with the intervention.

Primary Purpose: Health Services Research

Masking: None (Open Label)

Source: ClinicalTrials.gov